Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

Pharmacokinetics

Pharmacokinetics is the scientific term for the formalized study of how a drug is likely to behave in the body. It includes what happens when a drug moves into the body, through and then out of the body. Pharmacokinetics also involves examining and establishing the various patient-related factors which may predict a response within a population. In the pharmaceutical industry, it is imperative that all information about the behavior of a particular drug is known during preclinical development. This allows the developer to be aware of potential factors which could impact the behavior of a drug include genetic makeup, gender and age.

In is known for example, that physiologic factors such as food can affect many aspects of pharmacokinetics and other factors may relate directly to individual physiology, such as metabolism and clearance. These may be predicted from PK studies in animals or from PK modeling using software packages such as ADMET Predictor™ or GastroPlus™.

PharmaDirections’ PK experts have the capacity to work with you to design, develop and implement the necessary and relevant studies to ensure you achieve best practice results from your data. It is only by analyzing and interpreting the pharmacokinetic behavior of a particular drug, that the development pathway can proceed unhindered and optimal dosage forms be deemed correct.

  • Pharmacokinetics prediction from chemical structure and preformulation information
  • Human dose prediction from animal data
  • Dose and regime selection
  • Intellectual Property Generation (Learn more)
  • Pharmacokinetic modeling to predict oral bioavailability
  • Pharmacokinetic modeling to design controlled release formulations